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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stents, drains and dilators for the biliary ducts
510(k) Number K053454
Device Name RX HERCULINK ELITE BILIARY STENT SYSTEM
Applicant
GUIDANT CORPORATION
3200 Lakeside Drive
Santa Clara,  CA  95054
Applicant Contact KEITH KROHN
Correspondent
GUIDANT CORPORATION
3200 Lakeside Drive
Santa Clara,  CA  95054
Correspondent Contact KEITH KROHN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/09/2005
Decision Date 03/06/2006
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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